Early Onset Preeclampsia and Nectin-4

Sponsor

Hatice Akkaya (Other)

Overall Status

Completed

CT.gov ID

NCT05098691

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

10.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Early-onset Preeclampsia (PE) is a pregnancy disorder which may present with adverse pregnancy outcomes. Nectin-4 is an adhesion molecule mainly expressed in placenta. This study aimed to evaluate the relationship between early onset Preeclampsia and serum Nectin 4 levels.

Condition or Disease	Intervention/Treatment	Phase
Pre-Eclampsia Early Onset Preeclampsia Oxidative Stress Immunologic Diseases in Pregnancy	Diagnostic Test: serum marker levels

Detailed Description

Preeclampsia is assumed as a two-stage disorder arising from defective trophoblast invasion and failure of spiral artery remodeling as the main step responsible for the pathogenesis. PE is classified according to the disease onset time as early-onset PE before 34 weeks and late-onset PE after 34 weeks. Late-onset PE is more commonly seen and accepted as a mild maternal reaction to pregnancy. In early-onset PE, unlike the late-onset, due to the improper placental invasion, the diffuse placental ischemia and the resulting oxidative stress begin at early gestation. Thus, the early-onset PE may result in severe disease leading to perinatal and maternal morbidity and mortality.

The nectins are calcium-independent immunoglobulin-like celladhesion molecules and have a pivotal role at cellular junctions, as well as physiological regulations(8). Placenta expressesfor types of nectins; nectin-1, nectin-2, nectin-3, and nectin-4. They are localized at tight junctions and gap junctions of syncitiotrophoblasts(9). Nectin-4 is a relatively novel member of nectin family which has been detected only in placenta and airway epithelium in healthy subjects.

Despite, there has been no study published yet to reveal the soluble nectin-4 levels in preeclampsia as well as in early onset disease. In this study, we aimed to investigate the serum nectin-4 levels in early-onset preeclampsia in comparison of the healthy pregnancies.

Study Design

Study Type:

Observational

Actual Enrollment :

84 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Serum Nectin-4 Levels in Patients With Early Onset Preeclampsia

Actual Study Start Date :

May 1, 2020

Actual Primary Completion Date :

Dec 15, 2020

Actual Study Completion Date :

Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Group 1 (Early onset Preeclampsia ) 43 cases The groups were matched for gestational age and gravidity.	Diagnostic Test: serum marker levels two groups comparisons
Group 2 ( Healthy pregnant woman) control group 41 cases The groups were matched for gestational age and gravidity	Diagnostic Test: serum marker levels two groups comparisons

Arm

Intervention/Treatment

Group 1 (Early onset Preeclampsia )

43 cases The groups were matched for gestational age and gravidity.

Diagnostic Test: serum marker levels

two groups comparisons

Group 2 ( Healthy pregnant woman) control group

41 cases The groups were matched for gestational age and gravidity

Diagnostic Test: serum marker levels

two groups comparisons

Outcome Measures

Primary Outcome Measures

serum nectin-4 levels [1 hour]
ng/ml

Secondary Outcome Measures

BMI (body mass index) [5 minute]
kg/m2
Tansion Arterial [5 minute]
mm Hg

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

spontaneous,
singleton pregnancies
above the 24 weeks of gestations
positive fetal cardiac activity

Exclusion Criteria:

multiple gestations,
chronic hypertension
hypothyroidism
known malignancy,- diabetes mellitus,
presence of fetal or maternal infection,
clinical signs of chorioamnionitis (maternal fever, vaginal discharge, fetal tachycardia),
hepatic or renal failure
Placenta previa or pregnancies accompanied congenital fetal abnormalities or aneuploidies